The present invention relates generally to catheters, such as intravenous (“IV”) catheters, and more particularly to blood control valves for use in catheters.
Catheters are widely used throughout the medical community for a wide range of procedures and treatments. Catheters are commonly used for a variety of infusion therapies. Catheters are used for infusing fluid, such as normal saline solution, various medicaments, and total parenteral nutrition, into a patient, withdrawing blood from a patient, or monitoring various parameters of the patient's vascular system.
A common type of IV catheter is an over-the-needle peripheral IV catheter. As its name implies, an over-the-needle catheter is mounted over an introducer needle having a sharp distal tip. At least the distal portion of the catheter tightly engages the outer surface of the needle to prevent peelback of the catheter and thus facilitate insertion of the catheter into the blood vessel. The catheter and the introducer needle are assembled so that the distal tip of the introducer needle extends beyond the distal tip of the catheter with the bevel of the needle facing up away from the patient's skin. The catheter and introducer needle are generally inserted at a shallow angle through the patient's skin into a blood vessel.
The process of placing a catheter requires careful balance and control over the catheter. Typically an IV catheter will be incorporated into a catheter assembly. The catheter assembly may include various components to aid in the use and placement of the IV catheter. Typically a catheter assembly will provide a gripping surface to aid in griping and controlling the IV catheter during insertion. The gripping surface will commonly provide opposing surfaces whereby a user may grasp and hold the device during insertion.
FIG. 1 illustrates an example of a common IV catheter 100. Catheter 100 includes a catheter adapter 101 and a needle shield 103. A needle 102 is initially contained within a catheter extending out from catheter adapter 101. In some current IV catheters, catheter adapter 101 includes a septum through which needle 102 extends. The septum maintains a seal around needle 102 while the needle is inserted into the patient's vasculature so that blood cannot escape through catheter adapter 101 where it may come in contact with the external environment.
Once the catheter is placed inside the patient's vasculature, needle 102 can be withdrawn from catheter adapter 101 into needle shield 103. Once needle 102 is withdrawn, the septum can reseal to prevent blood from flowing out of catheter adapter 101 until another device (which usually has a male luer connector) is attached to the catheter adapter and separates the septum to allow fluid flow to or from the other device.
In some IV catheters, the catheter adapter includes an actuator that is forced through the septum when another device is attached to the catheter adapter. In other words, after the needle has been removed from the catheter adapter, the septum is again opened when a connector of the other device forces the actuator through the septum.
One problem that exists with current IV catheters that employ an actuator is that the actuator must be designed to remain within the catheter on the proximal side of the septum until activation (e.g. until the other device forces the actuator through the septum). Some designs of actuators for use in catheter adapters employ relatively small fixed arms that extend laterally from the actuator and snap into a small groove in the internal wall of the catheter adapter. To accommodate this design, the actuator and catheter adapter must be manufactured with tight tolerances. The tight tolerances are required to ensure that the fixed arms will fit into the grooves. Manufacturing these components with tight tolerances is oftentimes undesirable. For example, the cost or difficultly of manufacturing these components with tight tolerances may be burdensome or impractical in many cases.
Another problem with such designs is that the actuator, once forced through the septum, is only held in place by the friction between the septum and the nose of the actuator. In other words, the actuator is only held within the septum by the force that the septum applies around the actuator. No other structure is provided to ensure that the actuator does not slip back out from within the septum. Because of this, it is possible that the actuator may be disengaged from the septum which can inhibit the flow of fluids through the catheter adapter or otherwise affect the performance of the catheter.